Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209406
Company: WATSON LABS INC
Company: WATSON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/27/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209406Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/17/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
12/20/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
BRINZOLAMIDE
SUSPENSION/DROPS;OPHTHALMIC; 1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZOPT | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020816 | SANDOZ |
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 204884 | BAUSCH AND LOMB |
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 211914 | PADAGIS US |
BRINZOLAMIDE | BRINZOLAMIDE | 1% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 209406 | WATSON LABS INC |